Pharmaceutical compositions comprising meloxicam
Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a T max of meloxicam of 3 hours or less.
1 . A method of treating migraine, comprising orally administering a combination of a meloxicam, or a pharmaceutically acceptable salt thereof, and a rizatriptan, or a pharmaceutically acceptable salt thereof, to a human being in need thereof, wherein the combination of the meloxicam and the rizatriptan are administered at the onset of a migraine; wherein the combination is administered to treat 2 to 7 headaches in a month; and wherein the human being does not use a rescue medication within 24 hours of administration of the combination.
2 . The method of claim 1 , and wherein the combination contains about 10 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan.
3 . The method of claim 2 , wherein the human being experiences a reduction in migraine pain at 30 minutes after the combination of the meloxicam and the rizatriptan is orally administered.
4 . The method of claim 2 , wherein the human being experiences a reduction in migraine pain at 60 minutes after the combination of the meloxicam and the rizatriptan is orally administered.
5 . The method of claim 2 , wherein the human being experiences a reduction in migraine pain at 90 minutes after the combination of the meloxicam and the rizatriptan is orally administered.
6 . The method of claim 2 , wherein the human being experiences a reduction in migraine pain at 24 hours after the combination of the meloxicam and the rizatriptan is orally administered.
7 . The method of claim 2 , wherein the combination of the meloxicam and the rizatriptan contains about 20 mg of the meloxicam free acid, or a molar equivalent amount of a salt form of meloxicam.
8 . The method of claim 2 , wherein the human being experiences freedom from the human being's most bothersome migraine-associated symptom at two hours after the combination is orally administered, and wherein the human being's most bothersome migraine-associated symptom is nausea, photophobia, or phonophobia.
9 . The method of claim 1 , wherein the combination of the meloxicam and the rizatriptan contains about 20 mg of the meloxicam free acid, or a molar equivalent amount of a salt form of meloxicam.
10 . The method of claim 9 , wherein about 10 mg of the rizatriptan free base, or a molar equivalent amount of a salt of rizatriptan is administered once a day or less frequently.
11 . The method of claim 9 , wherein about 20 mg of the meloxicam free acid, or a molar equivalent amount of a salt form of meloxicam is administered once a day or less frequently.
12 . The method of claim 2 , wherein the migraine is associated with an aura.
13 . The method of claim 2 , wherein the human being does not use rescue medication after the combination of the meloxicam and the rizatriptan is orally administered.
14 . The method of claim 2 , wherein the human being achieves pain freedom by two hours after the combination of the meloxicam and the rizatriptan is orally administered.
15 . The method of claim 2 , wherein the human being achieves pain freedom by two hours after the combination of the meloxicam and the rizatriptan is orally administered, and wherein the pain freedom continues for at least 24 hours.
16 . The method of claim 2 , wherein the human being achieves pain freedom by two hours after the combination of the meloxicam and the rizatriptan is orally administered, and wherein the pain freedom continues for at least 48 hours.
17 . The method of claim 2 , wherein the human being has a patient global impression of change that is “much improved” or “very much improved” at two hours after the combination of the meloxicam and the rizatriptan is orally administered.
18 . The method of claim 2 , wherein the combination is in a dosage form, and wherein the dosage form has the property that orally administering the combination to a healthy human subject under fasted conditions results in a T max of meloxicam that is one hour or less.
19 . A method of treating migraine, comprising orally administering a combination of about 20 mg of meloxicam free acid, about 14.5 of rizatriptan benzoate, and sodium bicarbonate to a human being in need thereof, wherein the combination of the meloxicam free acid and rizatriptan benzoate are administered at the onset of a migraine; wherein the combination is administered to treat 2 to 7 headaches in a month; and wherein the human being does not use a rescue medication within 24 hours of administration of the combination.
20 . The method of claim 19 , wherein the combination further comprises sulfobutylether-β-cyclodextrin, or a pharmaceutically acceptable salt thereof.
21 . The method of claim 20 , wherein the sulfobutylether-β-cyclodextrin is sulfobutylether-β-cyclodextrin sodium.